Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Completed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2
In brief
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy
Key facts
- Study ID
- NCT04465877
- Run by
- Akros Pharma Inc.
- People needed
- 37
- Starts
- 2020-06-15
- Expected to finish
- 2021-02-17
- Last updated by the study team
- 2023-01-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
- Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
- Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
- Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
- Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)
You may not qualify if…
- Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
- Known medical history or presence of diabetic complications
- Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
- Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
- Have impaired renal function (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2)
Where it is running
- Qps-Mra, Llc — Miami, Florida, United States
Full record on ClinicalTrials.gov
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